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Serving 500+ biopharmaceutical companies globally:

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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065139

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NDA 065139 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Alvogen Inc, Watson Labs, Wockhardt, Loch, West-ward Pharms Int, Bristol Myers Squibb, Sagent Pharms, Ingenus Pharms Llc, G And W Labs Inc, Marsam Pharms Llc, Akorn, Solopak, Igi Labs Inc, Vintage Pharms, Fougera Pharms, Teva Parenteral, Boca Pharma Llc, Teligent Pharma Inc, Fresenius Kabi Usa, Abraxis Pharm, Perrigo New York, Fougera Pharms Inc, Bedford, Taro Pharm Inds, Perrigo Uk Finco, Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, Tolmar, Actavis Mid Atlantic, Baxter Hlthcare Corp, Akorn Inc, Celerity Pharms, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-six NDAs. It is available from twenty-three suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for NDA: 065139

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065139

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 065139

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
CREAM;VAGINAL 065139 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0277 0168-0277-40 40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
CREAM;VAGINAL 065139 ANDA PHARMADERM. A division of Nycomed US Inc. 0462-0277 0462-0277-40 40 g in 1 TUBE, WITH APPLICATOR (0462-0277-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrengthEQ 2% BASE
Approval Date:Dec 27, 2004TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Chubb
US Army
Johnson and Johnson
Covington
US Department of Justice
McKesson
Cipla
Express Scripts
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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